Transcatheter heart valve having paravalvular leakage seal

ABSTRACT

A transcatheter heart valve includes a paravalvular seal that is configured for transfemoral delivery. The valve includes a frame and the seal is formed from a plurality of outwardly extending fibers.

This application is a continuation of U.S. patent application Ser. No.18/210,674 entitled “TRANSCATHETER HEART VALVE HAVING PARAVALVULARLEAKAGE SEAL”, which was filed on Jun. 16, 2023, which is a continuationof U.S. patent application Ser. No. 16/935,261 entitled “DEVICE FORENDOVASCULAR AORTIC REPAIR AND METHOD OF USING THE SAME”, which wasfiled on Jul. 22, 2020, which is a continuation of U.S. patentapplication Ser. No. 16/808,137 entitled “HEART VALVE REPLACEMENT DEVICEFOR ENDOVASCULAR AORTIC REPAIR AND METHOD OF USING THE SAME”, which wasfiled on Mar. 3, 2020 and issued as U.S. Pat. No. 10,792,172 on Oct. 6,2020, which is a continuation of U.S. patent application Ser. No.16/736,879 entitled “DEVICE FOR ENDOVASCULAR AORTIC REPAIR AND METHOD OFUSING THE SAME”, which was filed on Jan. 8, 2020 and issued as U.S. Pat.No. 10,842,655 on Nov. 24, 2020, which is a continuation of U.S. patentapplication Ser. No. 16/042,286 entitled “DEVICE FOR ENDOVASCULAR AORTICREPAIR AND METHOD OF USING THE SAME”, which was filed on Jul. 23, 2018and issued as U.S. Pat. No. 10,555,823 on Feb. 11, 2020, which is acontinuation of U.S. patent application Ser. No. 14/614,628 entitled“Device for Endovascular Aortic Repair and Method of Using the Same”,which was filed on Feb. 5, 2015 and issued as U.S. Pat. No. 10,028,848on Jul. 24, 2018, which is a continuation of U.S. patent applicationSer. No. 14/569,306 entitled “Device for Endovascular Aortic Repair andMethod of Using the Same”, which was filed on Dec. 12, 2014 and issuedas U.S. Pat. No. 9,339,399 on May 17, 2016, which is a divisional ofU.S. patent application Ser. No. 13/706,896 entitled “Device forEndovascular Aortic Repair and Method of Using the Same”, which wasfiled on Dec. 6, 2012 and issued as U.S. Pat. No. 8,940,040 on Jan. 27,2015, which claims the benefit under 35 U.S.C. § 119 to U.S. ProvisionalApplication Ser. No. 61/567,458 entitled “Transcathetar Aortic Valve forEndovascular Aortic Repair”, which was filed on Dec. 6, 2011.Application Ser. No. 13/706,896 also claims priority under § 119 to U.S.Provisional Application Ser. No. 61/723,446 entitled “TranscatheterAortic Valve for Endovascular Aortic Repair”, which was filed on Nov. 7,2012. Each of the applications referenced herein are incorporated byreference in their entirety.

TECHNICAL FIELD

The present disclosure relates to a device and method of using same forendovascular aortic repair, including repair of aortic valve disease,aortic stenosis, ascending aortic aneurysms, aortic insufficiency,aortic regurgitation, ascending aneurysm, bicuspid valve disease, and/orType A dissections.

BACKGROUND

The normal aortic root and the ascending aorta are composed of theaortic annulus, the sinuses of Valsalva, the sinutubular junction, andthe tubular portion. The challenge facing practitioners of endovascularrepair of ascending aortic aneurysms is that there is a very shortproximal landing zone at the level of the sinutubular junction, there isvariable coronary anatomy from patient to patient, and, in many cases,there is involvement of the aortic valve with either stenosis orinsufficiency. Generally speaking, and as discussed in the articleSURGERY INSIGHT: THE DILATED ASCENDING AORTA—INDICATIONS FOR SURGICALINTERVENTION, by James E. Davies and Thralf M. Sundt published in NatureClinical Practice Cardiovascular Medicine (2007), the contents of whichare incorporated herein by reference in its entirety, there are threebasic types of involvement of the ascending aorta, designated as Type A,B, or C. These will be discussed in further detail below and are shownin FIGS. 1A-1C, which have been reproduced from the referenced article.

Type A aneurysms are most commonly found in younger patients andpatients with connective tissue disorders such as Marfan syndrome. Theanatomical characteristics of Type A aneurysms are dilatation of thesinuses of Valsalva with or without dilatation of the aortic annulus.The sinutubular junction is most often dilated. The valve could benormal, stenotic or insufficient. An example of a Type A aneurysm isshown in FIG. 1A.

The anatomical characteristics of Type B aneurysms are dilatation of thetubular portion. Initially the sinutubular junction may be normal ormildly dilated, however as the aneurysm grows, it stretches thesinutubular junction and may eventually lead to aortic insufficiency.The valve could be normal, stenotic or insufficient. The bulk of theaneurysm is at the level of the tubular aorta. An example of a Type Baneurysm is shown in FIG. 1B.

The anatomical characteristics of Type C aneurysms are dilatation of thesinuses of Valsalva, sinutubular junction and the tubular portion of theaorta. The valve could be normal, stenotic or insufficient. Type B and Caneurysms are most commonly found in an older group of patients. Anexample of a Type C aneurysm is shown in FIG. 1C.

There are devices clinically used for endovascular repair of ascendingaortic aneurysms. Although transcatheter valves are a clinical reality,none in clinical use have been designed with the purpose of endovascularrepair of multiple types of ascending aortic aneurysms. Indeed, a deviceis needed that can treat different anatomical variations of ascendingaortic aneurysms, create effective proximal and distal seal zones withinthe aorta, and have a durable valve component, but that also allows forfuture valve re-interventions. A device is also needed that would allowfor treatment of different coronary anatomical variations among thepatient population, allow future coronary re-intervention, but that alsoavoids coronary compression, and enables treatment of possibleparavalvular leaks.

SUMMARY

According to one aspect of the disclosure, an endograft device forendovascular repair of ascending aortic aneurysms is disclosed. Theendograft device includes a first prosthetic component that has aproximal frame and a distal frame that is secured to the proximal frameand extends to a distal end of the first prosthetic component. Theendograft device also includes at least one conduit that is secured tothe first prosthetic component and that is positioned adjacent to theproximal frame, and a second prosthetic component that is secured to aproximal end of the first prosthetic component. The second prostheticcomponent includes a balloon-expandable frame extending distally from aproximal end of the second prosthetic component and a self-expandingframe that is connected to the balloon-expandable frame and extends to adistal end of the second prosthetic component. The endograft device alsoincludes a valve element that is secured to the balloon-expandable frameat the proximal end of the second prosthetic component.

In some embodiments, the self-expanding frame may have an hourglassshape. In some embodiments, the self-expanding frame may include a firstsection that tapers inwardly between a proximal end and a distal end.The endograft device may also include a second section having a proximalend that is secured to the distal end of the first section. The secondsection may taper outwardly between the proximal end of the secondsection and a distal end of the second section. Additionally, in someembodiments, the proximal end of the first section may be connected to adistal end of the balloon-expandable frame.

In some embodiments, the self-expanding frame may include a thirdsection that extends proximally from the proximal end of the firstsection. The third section may have a passageway defined therein, andthe balloon-expandable frame may be positioned in the passageway of thethird section of the self-expanding frame. In some embodiments, theballoon-expandable frame may be expandable between an unexpandedposition in which an outer surface of the balloon-expandable frame isspaced apart from an inner surface of the self-expanding frame and anexpanded position in which the outer surface of the balloon-expandableframe is engaged with the inner surface of the self-expanding frame.

In some embodiments, a plurality of fibers may be attached to the thirdsection of the self-expanding frame. When the balloon-expandable frameis in the expanded position, the outer surface of the balloon-expandableframe may be engaged with the plurality of fibers.

In some embodiments, the proximal frame of the first prostheticcomponent may have a passageway defined therein, and the distal end ofthe second prosthetic component may be positioned in the passageway ofthe first prosthetic component.

In some embodiments, the conduit may include a pair of conduitspositioned on opposite sides of the first prosthetic component.Additionally, in some embodiments, the conduit may have a proximalopening that is positioned adjacent to a proximal end of the firstprosthetic component.

In some embodiments, the proximal frame may include a first sectionsecured to the distal end of the second prosthetic component, and asecond section connected to the first section. The second section maytaper outward between a proximal end connected to the first section anda distal end. The conduit may have a distal opening defined in thesecond section of the proximal frame.

Additionally, in some embodiments, the endograft device may include astent having a distal end positioned in the proximal opening of the atleast one conduit and a proximal end configured to be positioned in acoronary artery.

In some embodiments, an outer surface of the second prosthetic componentand an outer surface of the proximal frame of the first prostheticcomponent may be covered such that fluid is prevented from passingtherethrough. Additionally, an outer surface of the distal frame of thefirst prosthetic component may be uncovered such that is fluid permittedto pass therethrough.

According to another aspect, a transcatheter valve is disclosed. Thetranscatheter valve includes a frame component having aballoon-expandable frame extending distally from a proximal end of theframe component and a self-expanding frame secured to theballoon-expandable frame. The self-expanding frame includes a firstsection that tapers inwardly between a proximal end and a distal end,and a second section that tapers outwardly between a proximal endsecured to the distal end of the first section and a distal end. A valveelement is positioned in the balloon-expandable frame at the proximalend of the frame component.

In some embodiments, the frame component may be a dual-frame component.The self-expanding frame may be an outer frame of the dual-framecomponent and may have a passageway defined therein. Theballoon-expandable frame may be an inner frame of the dual-framecomponent that is positioned in the passageway defined in theself-expanding frame. Additionally, the balloon-expandable frame may beexpandable between an unexpanded position in which an outer surface ofthe balloon-expandable frame is spaced apart from an inner surface ofthe self-expanding frame and an expanded position in which the outersurface of the balloon-expandable frame is engaged with the innersurface of the self-expanding frame.

In some embodiments, a plurality of fibers may be attached to theself-expanding frame. When the balloon-expandable frame is in theexpanded position, the outer surface of the balloon-expandable frame maybe engaged with the plurality of fibers. Additionally, in someembodiments, an outer surface of the first section of the self-expandingframe may be uncovered such that fluid is permitted to pass therethroughand an outer surface of the second section of the self-expanding framemay be covered such that fluid is prevented from passing therethrough.

In some embodiments, the self-expanding frame may include an elongatedsection extending distally from the second section. The elongatedsection may have a length that is greater than a combined length of thefirst section and the second section. Additionally, in some embodiments,the self-expanding frame may be covered with at least one of a collagenand hydrogel. In some embodiments, the valve element may be one of abicuspid valve and a tricuspid valve.

According to another aspect, a method of repairing a patient's aorta isdisclosed. The method includes introducing a first prosthetic componentinto the patient's aorta such that a proximal frame of the firstprosthetic component is positioned in the ascending aorta and a distalframe of the first prosthetic component is positioned in the aortic archof the patient's aorta, advancing a covered stent through a conduitdefined in the first prosthetic component into a coronary artery of thepatient's aorta, securing a second prosthetic component to a proximalend of the first prosthetic component in the patient's aorta, andexpanding a proximal section of the second prosthetic component intoengagement with the aortic annulus of the patient's aorta such that avalve secured to the proximal section is positioned in the aorticannulus proximal to the coronary arteries.

In some embodiments, expanding the proximal section of the secondprosthetic component may include operating a balloon-expandable frame.Additionally, in some embodiments, expanding the proximal section of thesecond prosthetic component may include permitting a self-expandingframe to expand into engagement with the aortic annulus, and operatingthe balloon-expandable frame may include advancing an outer surface ofthe balloon-expandable frame into engagement with an inner surface ofthe self-expanding frame after the self-expanding frame is engaged withthe aortic annulus.

In some embodiments, operating the balloon-expandable frame may includeadvancing an outer surface of the balloon-expandable frame intoengagement with the aortic annulus.

In some embodiments, an outer surface of the second prosthetic componentand an outer surface of the proximal frame of the first prostheticcomponent may be covered such that fluid is prevented from passingtherethrough. Additionally, an outer surface of the distal frame of thefirst prosthetic component may be uncovered such that is permitted topass therethrough.

In some embodiments, introducing the first prosthetic component into thepatient's aorta and advancing the covered stent through the conduitdefined in the first prosthetic component into the coronary artery ofthe patient's aorta may be performed during a first surgical procedure.In some embodiments, securing the second prosthetic component to theproximal end of the first prosthetic component and expanding theproximal section of the second prosthetic component into engagement withthe aortic annulus of the patient's aorta may be performed during asecond surgical procedure different from the first surgical procedure.

In some embodiments, the method may also include introducing the secondprosthetic component into the ascending aorta prior to introducing thefirst prosthetic component.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described by way ofexample in greater detail with reference to the attached figures, inwhich:

FIG. 1 is an illustrative aorta;

FIG. 1A is an example of a Type A aneurysm;

FIG. 1B is an example of a Type B aneurysm;

FIG. 1C is an example of a Type C aneurysm;

FIG. 2 is partial cutaway view of an aorta with an embodiment of anendovascular prosthetic device implanted therein;

FIG. 3 is an elevation view of a proximal prosthetic component of theendovascular prosthetic device of FIG. 2 ;

FIG. 4 is an elevation view of a distal prosthetic component of theendovascular prosthetic device of FIG. 2 ;

FIG. 5 is a cross sectional view of the distal prosthetic component ofFIG. 4 taken along the line 5-5 in FIG. 4 ;

FIG. 6 is a partial cutaway view of the aorta with the distal prostheticcomponent of FIG. 3 implanted therein;

FIG. 7 is a view similar to FIG. 6 showing stents extending from thedistal prosthetic component;

FIG. 8 is an elevation view of another embodiment of a proximalprosthetic component of the endovascular prosthetic device of FIG. 2 ;

FIG. 9 is an elevation view of a self-expanding outer frame of theproximal prosthetic component of FIG. 8 ;

FIG. 10 is an elevation view of a balloon-expandable inner frame of theproximal prosthetic component of FIG. 8 ;

FIG. 11 is a perspective view a proximal end of the proximal prostheticcomponent of FIG. 8 ;

FIG. 12 is a cross-sectional elevation view of the proximal prostheticcomponent of FIG. 8 taken along the line 12-12 in FIG. 11 ;

FIG. 13 is a plan view of the proximal prosthetic component of FIG. 8showing the inner frame in an unexpanded position;

FIG. 14 is a plan view similar to FIG. 13 showing the inner frame in anexpanded position;

FIG. 15 is a partial cutaway view of the aorta with the distalprosthetic component of FIG. 4 secured to the proximal prostheticcomponent of FIG. 8 ;

FIG. 16 is a view similar to FIG. 15 showing the inner frame in anexpanded position;

FIG. 17 is an embodiment of a transcatheter valve device similar to theproximal prosthetic component of FIG. 3 ;

FIGS. 18-19 are partial cutaway views of the aorta with thetranscatheter valve of FIG. 17 implanted therein;

FIG. 20 is another embodiment of a transcatheter valve device similar tothe proximal prosthetic component of FIG. 8 ; and

FIGS. 21-22 are partial cutaway views of the aorta with thetranscatheter valve of FIG. 20 implanted therein.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been illustrated by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Terms representing anatomical references, such as anterior, posterior,medial, lateral, superior, inferior, distal, proximal, etcetera, may beused throughout the specification in reference to the orthopaedicimplants and surgical instruments described herein as well as inreference to the patient's natural anatomy. Such terms havewell-understood meanings in both the study of anatomy and the field oforthopaedics. Use of such anatomical reference terms in the writtendescription and claims is intended to be consistent with theirwell-understood meanings unless noted otherwise. For example, the term“proximal” refers to the direction that is generally closest to theheart, and the term “distal” refers to the direction that is generallyfurthest from the heart.

Referring to FIGS. 2-16 , exemplary designs of an endovascularprosthetic device or endograft device 10 (hereinafter device 10) areshown. The device 10 is intended for the treatment of most ascendingaortic aneurysms and is configured to treat any type of ascendinganeurysm regardless of involvement of the aortic valve and the sinusesof Valsalva. As described in greater detail below, the device 10 permitsfuture coronary and aortic valve interventions as well as extension of afenestrated/branch graft into the aortic arch. Part of the device 10 mayalso be modified and used as a transcatheter valve, as described ingreater detail below in regard to FIGS. 17-22. Such a valve may beintroduced transfemorally or through the subclavian artery or the apexof the heart.

Referring now to FIGS. 2-7 , the device 10 includes a proximal component12 that is attached to a distal component 14. As shown in FIG. 2 , thedistal component 14 may be secured to the proximal component 12 whenimplanted into a patient's aorta 16. When implanted, the proximalcomponent 12 is positioned in the patient's ascending aorta 18, whilethe distal component 14 extends distally into the arch 20 of thepatient's aorta 16. The distal component 14 includes a pair of“Endo-cabrol conduits” or conduits 22, and each conduit 22 is sized toreceive a catheter or stent 24 for coronary blood flow, as described ingreater detail below. The device 10 is configured to treat all ascendinganeurysms with or without dilated sinutubular junctions and aortic valvedisease.

As shown in FIG. 3 , the proximal component 12 includes a frame 26 thatextends from a proximal end 28 to a distal end 30. The frame 26 isattached to a valve 32 (shown in phantom), which is positioned at theproximal end 28 of the component 12. In the illustrative embodiment, thevalve 32 is configured as a bicuspid valve. It should be appreciatedthat in other embodiments the valve 32 may be tricuspid or quadracuspid.The valve 32 may be constructed from treated bovine pericardium or othersuitable proven biological or synthetic material. When the proximalcomponent 12 is implanted into the patient's aorta 16, the valve 32replaces the aortic valve and permits fluid (i.e., blood) to selectivelypass from the heart and into a passageway 36 extending through theproximal component 12.

The valve 32 is housed in a balloon-expandable frame 34 of the frame 26.As shown in FIG. 3 , the balloon-expandable frame 34 is embodied as aballoon-expandable stent 38 that extends distally from the proximal end28 of the component 12 and has a length 40 of approximately 15 mm. Inother embodiments, the stent 38 may be longer or shorter depending on,for example, the patient's anatomy. The stent 38 is tubular and isconstructed of a metallic material, such as, nitinol, stainless steel,or other implant grade metallic material, in an open-cell configuration.It should be appreciated that in other embodiments the stent 38 may beformed from a polymeric material and may be formed in, for example, aZ-stent configuration. In the illustrative embodiment, the outer surface42 of the stent 38 is covered with low-profile polyester, ePTFE, orother nonporous covering material 44 that prevents fluid from passingthrough the outer surface 42. However, it should be appreciated that thestent 38 may be covered with standard polyester or other nonporousmaterials.

As shown in FIG. 3 , the stent 38 of the balloon-expandable frame 34 hasa diameter 46. As described in greater detail below, theballoon-expandable frame 34 is expandable during implantation from anunexpanded diameter (not shown) to the expanded diameter 46. In theillustrative embodiment, the expanded diameter 46 is equal toapproximately 26 mm when the frame 34 is expanded. In other embodiments,the expanded diameter may be greater than or less than 26 mm dependingon, for example, the patient's anatomy. Examples of balloon-expandablestents are described in U.S. Pat. No. 5,102,417 entitled “ExpandableIntraluminal Graft, and Method and Apparatus for Implanting anExpandable Intraluminal Graft” by Julio C. Palmaz and U.S. Pat. No.6,582,462 entitled “Valve Prosthesis for Implantation in the Body and aCatheter for Implanting Such Valve Prosthesis” by Henning Rud Andersenet al., which are expressly incorporated herein by reference. In theillustrative embodiment, the diameter 46 is oversized relative to thediameter of the aortic annulus 210 (see FIG. 1 ) such that aninterference fit is created between the stent 38 and the annulus 210when the component 12 is implanted and the stent 38 is expanded, asdescribed in greater detail below.

The balloon-expandable frame 34 is attached to a self-expanding frame50. In the illustrative embodiment, the distal end 52 of theballoon-expandable frame 34 is secured to the proximal end 54 of theframe 50 by stitching or sewing the frames 34, 50 together, therebyforming the frame 26 of the component 12. It should be appreciated thatin other embodiments the frames 34, 50 may be secured together viawelding or other fasteners. The frames 34, 50 may also be formed as asingle, monolithic frame.

As shown in FIG. 3 , the self-expanding frame 50 has a generallyhourglass shape and is formed from a metallic material, such as,nitinol, stainless steel, or other implant grade metallic material. Itshould be appreciated that in other embodiments the frame 50 may beformed from a polymeric material. The frame 50 includes an inwardlytapered proximal section 60, an outwardly tapered middle section 62, andan elongated distal section 64. The section 60 includes the proximal end54 of the frame 50 and has a distal end 66 connected to the proximal end68 of the outwardly tapered middle section 62. The section 60 tapersinwardly between the ends 54, 66 from approximately 26 mm at the end 54to approximately 22 mm at the end 66. In the illustrative embodiment,the proximal section 60 has a length 70 of approximately 10 mm. Itshould be appreciated that in other embodiments the dimensions of thesection 60 may vary depending on, for example, the patient's anatomy.

The outwardly tapered middle section 62 of the self-expanding frame 50has the proximal end 68 and a distal end 72 connected to the proximalend 74 of the elongated distal section 64. The section 62 tapersoutwardly from a diameter of approximately 22 mm at the end 68 to adiameter of approximately 28 mm at the end 72. In the illustrativeembodiment, the middle section 62 has a length 76 of approximately 10mm. In other embodiments, the dimensions of the section 62 may varydepending on, for example, the patient's anatomy. Among other things,the tapered sections 60, 62 of the proximal component 12 permit theplacement of the stents 24 that extend from the distal component 14 tothe coronary arteries, as described in greater detail below.

The elongated distal section 64 of the self-expanding frame 50 extendsdistally from the proximal end 74 to the distal end 30 of the component12. In the illustrative embodiment, the section 64 has a length 78 thatis greater than the combined length of the tapered sections 60, 62. Inone particular non-limiting example, the length 78 of the elongateddistal section 64 is approximately 25 mm and has a diameter 80 ofapproximately 28 mm. In other embodiments, the dimensions of the section64 may vary depending on, for example, the patient's anatomy. In oneexemplary embodiment, the distal section 64 may taper between theproximal end 74 and the distal end 30.

As shown in FIG. 3 , the proximal section 60 of the self-expanding frame50 is formed in an open-cell stent configuration, and the sections 62,64 are formed in a Z-stent configuration. It should be appreciated thatin other embodiments the sections 60, 62, 64 may be formed in a singleconfiguration, including an open-cell stent configuration or Z-stentconfiguration. The sections 60, 62, 64 may also be formed as a singlemonolithic component. The outer surface 82 of the self-expanding frame50 is covered with low profile polyester, ePTFE, or other nonporouscovering material 84 such that fluid is prevented from passing throughthe surface 82. In that way, the entire outer surface of the component12 is covered to prevent fluid from passing therethrough. The coveringmaterial 84 immediately distal to the balloon-expandable frame 34 isequipped with a “trap door” 86, which may be opened to permit thepassage of one or more surgical instruments for embolization of possibleparavalvular leaks. The entire outer surface of component 12 may be alsocovered with low-profile Dacron or other synthetic material. It shouldalso be appreciated that all or part of the component 12 may be coveredwith hydrogel or other sealing material.

As described above, the device 10 also includes a distal component 14,which is secured to the distal end 30 of the proximal component 12 whenthe device 10 is implanted in the patient's aorta 16. Referring now toFIG. 4 , the distal component 14 includes a frame 100 that extends froma proximal end 102 configured to be secured to the proximal component 12to a distal end 104. The frame 100 has a passageway 106 defined therein,which extends through the ends 102, 104 of the component 14. Thepassageway 106 has a diameter 108 and is sized to receive the distal end30 of the proximal component 12 when the device 10 is assembled.

In the illustrative embodiment, the components 12, 14 are securedtogether via an interference fit between the frame 100 and the distalend 30 of the proximal component 12. Specifically, the diameter 108 ofthe passageway 106 is less than the diameter 80 of the proximalcomponent 12. In the illustrative embodiment, the diameter 108 is equalto approximately 26 mm. It should be appreciated that in otherembodiments the components 12, 14 may be secured together via stitchingor other fastening means.

As shown in FIG. 4 , the component 14 includes a proximal frame 110 thatis connected to an elongated distal frame 112. The proximal frame 110and the distal frame 112 are formed from metallic materials, such as,nitinol, stainless steel, or other implant grade metallic materials. Itshould be appreciated that in other embodiments the frames 110, 112 maybe formed from a polymeric material. The proximal frame 110 is formed ina Z-stent configuration, and the distal frame 112 is formed in anopen-cell configuration. Each of the frames 110, 112 is self-expanding.In the illustrative embodiment, the distal frame 112 is secured to thedistal end 114 of the proximal frame 110 by stitching or sewing theframes 110, 112 together. It should be appreciated that in otherembodiments the frames 110, 112 may be secured together via welding orother fasteners. The frames 110, 112 may also be formed as a single,monolithic frame.

The proximal frame 110 has an outer surface 120 that is covered with lowprofile polyester, ePTFE, or other nonporous covering material 122. As aresult, fluid is prevented from passing through the surface 120. Thedistal frame 112 is uncovered such that fluid is permitted to passthrough the openings 124 formed therein.

As shown in FIG. 4 , the proximal frame 110 includes a proximal section126, an outwardly tapered section 128 extending distally from theproximal section 126, and an elongated distal section 130. The proximalsection 126 includes the proximal end 102 of the component 14 and has adistal end 132 connected to the proximal end 134 of the outwardlytapered section 128. In the illustrative embodiment, the proximalsection 126 has a length 136 of approximately 25 mm. It should beappreciated that in other embodiments the dimensions of the section 126may vary depending on, for example, the patient's anatomy.

The tapered section 128 of the frame 110 has the proximal end 134 and adistal end 140 connected to the proximal end 142 of the elongated distalsection 130. The section 128 tapers outwardly from a diameter ofapproximately 26 mm at the end 132 to a diameter between approximately44 mm and 48 mm at the end 140. In the illustrative embodiment, thetapered section 128 has a length 146 of approximately 10 mm. It shouldbe appreciated that in other embodiments the dimensions of the section128 may vary depending on, for example, the patient's anatomy.

The elongated distal section 130 of the frame 110 extends distally fromthe proximal end 142 to the distal end 114 of the frame 110. In theillustrative embodiment, the section 130 has a length 150. In oneparticular non-limiting example, the length 150 of the elongated distalsection 130 is approximately 20 mm. The section 130 also has a diameter152 of between approximately 44 mm and 48 mm. In other embodiments, thedimensions of the section 130 may vary depending on, for example, thepatient's anatomy.

As described above, the distal component 14 also includes a pair ofconduits 22, which are connected to the proximal frame 110. Each conduit22 has a distal end 160 secured to the tapered section 128 of the frame110 and a proximal end 162 positioned adjacent to the proximal end 102of the component 12. As shown in FIG. 4 , the conduit 22 does not extendbeyond the proximal end 102 of the component 12. Each conduit 22 has apassageway 164 that extends through the ends 160, 162 and is sized toreceive a stent 24.

The passageway 164 has a proximal opening 166 defined in the end 162.The opening 166 has a diameter 168 that in the exemplary embodiment isequal to approximately 5 mm. As shown in FIG. 5 , the passageway 164 hasa distal opening 170 that is defined in the end 160 and the taperedsection 128 of the frame 110. The distal opening 170 has a diameter 172that is greater than the diameter 168. In the illustrative embodiment,the diameter 172 is equal to approximately 8 mm. The passageway 164measures approximately 8 mm in diameter over a distance 174 ofapproximately 5 mm and tapers smoothly into the approximately 5 mmdiameter 168 at a junction 176. The passageway 164 maintains thediameter 168 between the junction 176 and the proximal opening 166. Inthe illustrative embodiment, the passageway 164 has a length 180 ofapproximately 2 cm between the junction 176 and the proximal opening166.

Each conduit 22 is wire reinforced and allows for passage of cathetersor stents 24 and easier cannulation of the coronary ostia, regardless ofdeployment orientation. This configuration allows stenting of thecoronary arteries 182 (see FIG. 1 ) prior to the deployment of component12, as described in greater detail below. In the illustrativeembodiment, the tapered section 128 permits the uncompromised passage ofstents 24 into the coronary arteries 182 in such a way that the stentsare not compressed between the sinutubular junction and the device 10itself.

As shown in FIG. 4 , the elongated distal frame 112 of the component 14extends distally from the distal end 114 of the frame 110 to the distalend 104 of the component 14. In the illustrative embodiment, the frame112 has a length 190. In one particular non-limiting example, the length190 of the elongated frame 112 is approximately 10 cm, which issufficient to cover the arch 20 of the aorta 18 when implanted therein.In other embodiments, the dimensions of the frame 112 may vary dependingon, for example, the patient's anatomy. The distal frame 112 permits theaccurate deployment of component 14 without compromising the circulationto supra-aortic branches. It also allows for cannulation of thesupra-aortic branches, if placement of a fenestrated/branch arch deviceis necessary.

To implant the device 10 in the patient's aorta 16, a surgeon may obtainopen exposure or percutaneous access to the common femoral artery. Theiliac arteries or an iliac conduit may also be used. After obtainingaccess and placing a stiff wire in the ascending aorta 18, the device 10and the delivery system are prepared. In the illustrative embodiment,the delivery system is composed of a 100-105 cm hydrophilic sheath. Asshown in FIG. 6 , the distal component 14 is delivered first. Afterperforming a lateral oblique thoracic aortogram, the component 14 isdeployed such that the distal end 114 of the proximal frame 110 ispositioned proximal to the innominate artery 200, thereby ensuring thatthe distal openings 170 of the conduits 22 are at 12 and 6 o'clockpositions in relationship to the innominate artery 200.

Using the contralateral common femoral artery wires, standard coronaryguide catheters are introduced through the distal frame 112 of thecomponent 14 into each conduit 22. The conduits 22 may then becannulated with the catheters prior to insertion of the stents 24.Alternatively, the conduits 22 may be pre-cannulated. Using thecatheters, access is obtained to the right and left coronary arteries182. The stents 24 are advanced into the passageways 164 through thedistal openings 170 and out of the conduits 22 to bridge the arteries182 and the conduits 22, as shown in FIG. 7 . In that way, each artery182 is connected to its respective conduit 22. Each stent 24 is coveredand may be embodied as a balloon-expandable stent or a self-expandingstent. It should be appreciated that coronary artery bypasses may beperformed to the right and left coronary systems prior to the placementof the component 14.

The proximal component 12 may be deployed after the implantation of thedistal component 14. The components 12, 14 may be deployed in a singlesurgical procedure taking place on a single day or the component 14 maybe deployed in one procedure, and the component 12 may be deployed inanother, separate procedure at a later date. As shown in FIG. 1 , theproximal component 12 is deployed into the position across the nativeaortic valve 202.

To do so, a stiff wire is passed through the aortic valve 202 into theleft ventricle 204. The delivery system for the proximal component 12 ispassed through the valve 202. An example of a delivery system isdescribed in U.S. Pat. No. 5,102,417 entitled “Expandable IntraluminalGraft, and Method and Apparatus for Implanting an ExpandableIntraluminal Graft” by Julio C. Palmaz, which is incorporated herein byreference. When the delivery system is in position, the proximalcomponent 12 is released by unsheathing the system, thereby permittingexpansion of the self-expanding frame 50. As described above, theself-expanding frame 50 engages the proximal end 102 of the distalcomponent 14 to secure the components 12, 14 together and seal thedistal end 30 of the component 12 within the distal component 14. Asshown in FIG. 2 , the proximal end 28 of the proximal component 12 ispositioned in the aortic annulus, and the hour-glass shape of thecomponent 12 provides a space for the native aortic valve leaflets suchthat the leaflets are not pressed against or over the openings ofcoronary arteries 182.

The balloon-expandable frame 34 may be now deployed by inflating theballoon within the delivery system. This deploys the frame 34 to thepredetermined expanded diameter 46 and advances the frame 34 intoengagement with the aortic annulus 210, thereby sealing the aorticannulus 210 such that fluid is permitted to pass from the left ventricle204 only through the valve 32. As shown FIG. 1 , the valve 32 ispositioned in the aortic annulus 210 proximal to the coronary arteries182. It should be appreciated that the deployment of the component 12may be performed during rapid ventricular pacing (RVP). In cases withaortic stenosis, the valve 32 may be dilated with balloon angioplastyprior to the introduction of the proximal component 12.

Referring now to FIGS. 8-16 , another embodiment of a proximal component212 of the device 10 is shown. Some features of the embodimentillustrated in FIGS. 8-16 are substantially similar to those describedabove in reference to the embodiment of FIGS. 1-7 . Such features aredesignated in FIGS. 8-16 with the same reference numbers as those usedin FIGS. 1-7 . Similar to the proximal component 12 of FIGS. 1-7 , theproximal component 212 may be secured to the distal component 14 whenimplanted into a patient's aorta 16. When implanted, the proximalcomponent 212 is positioned in the patient's ascending aorta 18, whilethe distal component 14 extends distally into the arch 20 of thepatient's aorta 16.

As shown in FIG. 8 , the proximal component 212 includes a dual-frame214 that extends from a proximal end 28 to a distal end 30. The frame214 is attached to a valve 32 (shown in phantom), which is positioned atthe proximal end 28 of the component 212. In the illustrativeembodiment, the valve 32 is configured as a bicuspid valve. It should beappreciated that in other embodiments the valve 32 may be tricuspid orquadracuspid. The valve 32 may be constructed from treated bovinepericardium or other suitable proven biological or synthetic material.When the proximal component 212 is implanted into the patient's aorta16, the valve 32 replaces the aortic valve and permits fluid (i.e.,blood) to selectively pass from the heart and into a passageway 36extending through the proximal component 212.

The dual-frame 214 of the proximal component 212 includes aself-expanding outer frame 216 and a balloon-expandable inner frame 218that is secured to the self-expanding outer frame 216 and houses thevalve 32. Referring now to FIG. 9 , the self-expanding outer frame 216has a generally hourglass shape and is formed from a metallic material,such as, nitinol, stainless steel, or other implant grade metallicmaterial. It should be appreciated that in other embodiments the outerframe 216 may be formed from a polymeric material. The outer frame 216includes an elongated proximal section 220, an inwardly tapered section222, an outwardly tapered middle section 62, and an elongated distalsection 64.

The elongated proximal section 220 of the outer frame 216 includes theproximal end 28 of the component 212 and has a distal end 224 connectedto a proximal end 226 of the inwardly tapered section 222. The proximalsection 220 is embodied as a tubular stent. It should be appreciatedthat in other embodiments the section 220 may be shaped as a prism,cone, or other geometric shape depending on the patient's anatomy.

In the illustrative embodiment, the proximal section 220 has a length228 that is equal to approximately 15 mm. The proximal section 220 alsohas a diameter 230 of approximately 32 mm. It should be appreciated thatin other embodiments the dimensions of the frame 216 may vary accordingto the anatomy of the patient. In the illustrative embodiment, thediameter 230 is oversized relative to the diameter of the aortic annulus210 such that an interference fit is created between the proximalsection 220 and the annulus 210 when the component 212 is implanted, asdescribed in greater detail below. As shown in FIG. 9 , the proximalsection 220 defines a passageway 232 in the outer frame 216.

In the illustrative embodiment, collagen fibers 234 are attached to theproximal section 220 to aid in preventing paravalvular leaks andmigration of the proximal component 212 within the aortic walls. Thefibers 234 extend outwardly from the proximal section 220 and inwardlyinto the passageway 232. It should be appreciated that in otherembodiments the outer frame 216 may be covered with hydrogel or othersealing materials. In other embodiments, a plurality of barbs or hooksmay be attached to the proximal section 220. The hooks may be configuredto further engage the tissue of the aorta and inhibit or preventmigration of the device 10.

The inwardly tapered section 222 of the outer frame 216 includes theproximal end 226 and has a distal end 236 connected to the proximal end68 of the outwardly tapered middle section 62. The section 222 tapersinwardly between the ends 226, 236 from approximately 32 mm at the end226 to approximately 22 mm at the end 236. In the illustrativeembodiment, the inwardly tapered section 222 has a length 238 ofapproximately 10 mm.

The outwardly tapered middle section 62 of the self-expanding frame 216has the proximal end 68 and a distal end 72 connected to the proximalend 74 of the elongated distal section 64. The section 62 tapersoutwardly from a diameter of approximately 22 mm at the end 68 to adiameter of approximately 28 mm at the end 72. In the illustrativeembodiment, the middle section 62 has a length 76 of approximately 10mm. In other embodiments, the dimensions of the section 62 may varydepending on, for example, the patient's anatomy.

The elongated distal section 64 of the self-expanding frame 216 extendsdistally from the proximal end 74 to the distal end 30 of the component212. In the illustrative embodiment, the section 64 has a length 78 thatis greater than the combined length of the tapered sections 60, 62. Inone particular non-limiting example, the length 78 of the elongateddistal section 64 is approximately 30 mm and has a diameter 80 ofapproximately 34 mm. In other embodiments, the dimensions of the section64 may vary depending on, for example, the patient's anatomy. In oneexemplary embodiment, the distal section 64 may taper between theproximal end 74 and the distal end 30.

As shown in FIG. 9 , the proximal section 220 and the inwardly taperedsection 222 of the self-expanding frame 216 are formed in an open-cellstent configuration, and the sections 62, 64 are formed in a Z-stentconfiguration. It should be appreciated that in other embodiments thesections 62, 64, 220, 222 may be formed in a single configuration,including an open-cell stent configuration or Z-stent configuration. Thesections 62, 64, 220, 222 may also be formed as a single monolithiccomponent. The outer surface 240 of the sections 62, 64, 222 are coveredwith low profile polyester, ePTFE, or other nonporous covering material242 such that fluid is prevented from passing through the surface 240.The covering material 242 immediately distal to the proximal section 220is equipped with a “trap door” 86, which may be opened to permit thepassage of one or more surgical instruments for embolization of possibleparavalvular leaks. The outer surface 240 of the sections 62, 64, 222may be also covered with low-profile Dacron or other synthetic material.It should also be appreciated that all or part of the frame 216 may becovered with hydrogel or other sealing material.

As described above, the outer frame 216 of the dual-frame 214 is securedto a balloon-expandable inner frame 218, which is positioned in thepassageway 232. As shown in FIG. 10 , the frame 218 houses the valve 32.The balloon-expandable frame 218 is embodied as a balloon-expandabletubular stent 244 that has a length 246 of approximately 15 mm. In otherembodiments, the stent 244 may be longer or shorter depending on, forexample, the patient's anatomy. The stent 244 is tubular and isconstructed of a metallic material, such as, nitinol, stainless steel,or other implant grade metallic material, in an open-cell configuration.It should be appreciated that in other embodiments the stent 244 may beformed from a polymeric material and may be formed in, for example, aZ-stent configuration. In the illustrative embodiment, the outer surface248 of the stent 244 is covered with low-profile polyester, ePTFE, orother nonporous covering material 250 that prevents fluid from passingthrough the outer surface 248. However, it should be appreciated thatthe stent 244 may be covered with standard polyester, ePTFE or othernonporous materials.

As shown in FIG. 10 , the stent 244 of the inner frame 218 has adiameter 252. As described in greater detail below, theballoon-expandable frame 218 is expandable during implantation from anunexpanded diameter (not shown) to the expanded diameter 252. In theillustrative embodiment, the expanded diameter 252 is equal toapproximately 26 mm when the inner frame 218 is expanded. In otherembodiments, the expanded diameter may be equal to, or greater than, thediameter 230 of the proximal section 220 of the outer frame 216. In theillustrative embodiment, the expanded diameter 252 is oversized relativeto the diameter of the aortic annulus 210 such that an interference fitis created between the proximal section 220 and the annulus 210 when thecomponent 212 is implanted, and the inner frame 218 is expanded, asdescribed in greater detail below.

Referring now to FIG. 11 , the inner frame 218 of the dual-framecomponent 214 is secured to the outer frame 216 via a plurality ofstitches 260. It should be appreciated that in other embodimentssoldering, welding or other fasteners may be used to secure the innerframe 218 to the outer frame 216. As shown in FIGS. 11-14 , the innerframe 218 and the valve component 32 are positioned in the passageway232 defined in the self-expanding frame 216. When the inner frame 218 isunexpanded, the outer surface 248 of the stent 244 is spaced apart fromthe fibers 234 attached to the outer frame 216. In the illustrativeembodiment, a gap 264 is defined therebetween, and the gap 264 has amagnitude of about 2 mm to about 3 mm.

As shown in FIG. 14 , the balloon-expandable inner frame 218 may beexpanded in the direction indicated by arrows 266. As described above,the diameter 230 of the proximal section 220 of the outer frame 216 isoversized relative to the diameter of the aortic annulus 210. As such,when the component 212 is implanted, the proximal section 220 is reducedto the diameter of the annulus 210. Because the expanded diameter 252 ofthe stent 244 is greater than the diameter of the annulus, the outersurface 248 of the stent 244 engages the fibers 234 (and hence the innersurface of the proximal section 220 of the outer frame 216) through thecovering material 250. In that way, the gap 264 is closed, and thefibers 234 and the covering material 250 create a seal between the innerframe 218 and the outer frame 216.

To implant an endograft device 10 that includes proximal component 212in the patient's aorta 16, a surgeon may obtain open exposure orpercutaneous access to the common femoral artery. The surgeon may thenimplant the distal component 14 in the manner described above in regardto FIGS. 1-7 and advance the stents 24 into position in the arteries182. The proximal component 212 may be deployed after the implantationof the distal component 14. To do so, a stiff wire is passed through theaortic valve 202 into the left ventricle 204. The delivery system forthe proximal component 212 is then passed through the valve 202.

When the delivery system is in position, the proximal component 212 isreleased by unsheathing the system, thereby permitting expansion of theself-expanding frame 216. The self-expanding frame 216 engages theproximal end 102 of the distal component 14 to secure the components212, 14 together and seal the distal end 30 of the component 212 withinthe distal component 14.

When the frame 216 is unsheathed, the proximal section 220 expands intoengagement with the aortic annulus 210, thereby creating an interferencefit between the frame 216 and the annulus 210 and stabilizing the device10 in place. As shown in FIG. 15 , the inner frame 218 is initiallyunexpanded within the outer frame 216. The inner frame 218 may bedeployed by expanding the balloon assembly. Expansion of theballoon-expandable inner frame 218 engages the inner frame 218 with theouter frame 216 and compresses the collagen fiber/hydrogel coatedproximal section 220 of the outer frame 216 against the aortic annulus210. As shown in FIG. 16 , the combined engagement of the frames 216,218 seals the annulus 210 and the paravalvular areas, and thus, preventsparavalvular leakage. As such, fluid is permitted to pass from the leftventricle 204 only through the valve 32 of the component 212. As shownFIGS. 15-16 , the valve 32 is positioned in the aortic annulus 210proximal to the coronary arteries 182. It should be appreciated that thedeployment of the component 212 may be performed during rapidventricular pacing (RVP). In cases with aortic stenosis, the valve 32may be dilated with balloon angioplasty prior to the introduction of theproximal component 212.

In each of the embodiments described above, the self-expanding frameportion of proximal components 12, 212 significantly improves theaccuracy and control of the deployment of the device 10. The bicuspidconfiguration of the valve 32 serves three distinct purposes, including(1) by reducing the number of valve commissures to two, the profile willbe reduced, (2) the valve 32 may conform better to the aortic annulus,and (3) when the annulus is asymmetrical, the incidence of aorticinsufficiency may be reduced.

Referring now to FIGS. 17-22 , the proximal component 12 or the proximalcomponent 212 may be used as a transcatheter valve with slightmodification. Such a valve may be deployed via a transfemoral ortrans-axillary route, as will be described in further detail below.

Referring now to FIGS. 17-19 , one embodiment of a transcatheter valvecomponent 312 is shown. Some features of the embodiment illustrated inFIGS. 17-19 are substantially similar to those described above inreference to the proximal component 12 of FIGS. 1-7 . Such features aredesignated in FIGS. 17-19 with the same reference numbers as those usedin FIGS. 1-7 . Similar to the proximal component 12 of FIGS. 1-7 , thetranscatheter valve component 312 includes a frame 26 that extends froma proximal end 28 to a distal end 30. The frame 326 is attached to avalve 32 (shown in phantom), which is positioned at the proximal end 28of the valve component 312. When the valve component 312 is implantedinto the patient's aorta 16, the valve 32 replaces the aortic valve andpermits fluid (i.e., blood) to selectively pass from the heart and intoa passageway 36 extending through the valve component 312.

The valve 32 is housed in a balloon-expandable frame 34 of the frame 26.As shown in FIG. 17 , the balloon-expandable frame 34 is embodied as aballoon-expandable stent 38 that extends distally from the proximal end28 of the transcatheter valve component 312 and has a length 40 ofapproximately 15 mm. In other embodiments, the stent 38 may be longer orshorter depending on, for example, the patient's anatomy. The stent 38is tubular and is constructed of a metallic material, such as, nitinol,stainless steel, or other implant grade metallic material, in anopen-cell configuration. It should be appreciated that in otherembodiments the stent 38 may be formed from a polymeric material and maybe formed in, for example, a Z-stent configuration. In the illustrativeembodiment, the outer surface 42 of the stent 38 is covered withlow-profile polyester, ePTFE, or other nonporous covering material 44that prevents fluid from passing through the outer surface 42. However,it should be appreciated that the stent 38 may be covered with standardpolyester, ePTFE or other nonporous materials.

As shown in FIG. 17 , the stent 38 of the balloon-expandable frame 34has a diameter 46. As described in greater detail below, theballoon-expandable frame 34 is expandable during implantation from anunexpanded diameter (not shown) to the expanded diameter 46. In theillustrative embodiment, the expanded diameter 46 is equal toapproximately 26 mm when the frame 34 is expanded. In other embodiments,the expanded diameter may be greater than or less than 26 mm dependingon, for example, the patient's anatomy. In the illustrative embodiment,the diameter 46 is oversized relative to the diameter of the aorticannulus 210 such that an interference fit is created between the stent38 and the annulus 210 when the transcatheter valve component 312 isimplanted.

The balloon-expandable frame 34 is attached to a self-expanding frame350. In the illustrative embodiment, the distal end 52 of theballoon-expandable frame 34 is secured to the proximal end 54 of theframe 350 by stitching or sewing the frames 34, 350 together, therebyforming the frame 26 of the transcatheter valve component 312. It shouldbe appreciated that in other embodiments the frames 34, 350 may besecured together via welding or other fasteners. The frames 34, 350 mayalso be formed as a single, monolithic frame.

As shown in FIG. 17 , the self-expanding frame 350 has a generallyhourglass shape and is formed from a metallic material, such as,nitinol, stainless steel, or other implant grade metallic material. Itshould be appreciated that in other embodiments the frame 350 may beformed from a polymeric material. The frame 350 includes an inwardlytapered proximal section 360, an outwardly tapered middle section 62,and an elongated distal section 64. The section 360 includes theproximal end 54 of the frame 350 and has a distal end 66 connected tothe proximal end 68 of the outwardly tapered middle section 62. Thesection 360 tapers inwardly between the ends 54, 66 from approximately26 mm at the end 54 to approximately 22 mm at the end 66. In theillustrative embodiment, the proximal section 360 has a length 70 ofapproximately 15 mm.

The outwardly tapered middle section 62 of the self-expanding frame 350has the proximal end 68 and a distal end 72 connected to the proximalend 74 of the elongated distal section 64. The section 62 tapersoutwardly from a diameter of approximately 22 mm at the end 68 to adiameter of approximately 28 mm at the end 72. In the illustrativeembodiment, the middle section 62 has a length 76 of approximately 10mm. In other embodiments, the dimensions of the section 62 may varydepending on, for example, the patient's anatomy.

The elongated distal section 64 of the self-expanding frame 350 extendsdistally from the proximal end 74 to the distal end 30 of the valvecomponent 312. In the illustrative embodiment, the section 64 has alength 78 that is greater than the combined length of the taperedsections 60, 62. In one particular non-limiting example, the length 78of the elongated distal section 64 is approximately 30 mm and has adiameter 80 of approximately 34 mm. In other embodiments, the dimensionsof the section 64 may vary depending on, for example, the patient'sanatomy. In one exemplary embodiment, the distal section 64 may taperbetween the proximal end 74 and the distal end 30.

As shown in FIG. 3 , the proximal section 360 of the self-expandingframe 350 is formed in an open-cell stent configuration, and each of thesections 62, 64 is formed in a Z-stent configuration. It should beappreciated that in other embodiments the sections 360, 62, 64 may beformed in a single configuration, including the open-cell stentconfiguration, mesh-like stent configuration, or Z-stent configuration.The sections 60, 62, 64 may also be formed as a single monolithiccomponent.

As shown in FIG. 17 , the outer surface 314 of the proximal section 360of the frame 350 is uncovered such that fluid is permitted to passthrough the openings 318. The outer surface 316 of the sections 62, 64are covered with low profile polyester, ePTFE, or other nonporouscovering material 84 such that fluid is prevented from passing throughthe surface 320. The outer surface 320 of the valve component 312 mayalso be covered with low-profile Dacron or other synthetic material. Theuncovered, open cell stent section 360 is configured to allow forcoronary artery perfusion. The covered sections 62, 64 serve tostabilize the valve component 312 against the aorta 18 and provide adocking station to ascending aortic extensions or fenestrated/brancharch grafts. The covered sections 62, 64 would also permit endograftextension of the valve component 312 for suitable type B aneurysmswithout dilation of the sinutubular junction.

The delivery of the transcatheter valve component 312 may begin bygaining access to the left ventricle across the native aortic valve. Anascending aortogram may be performed to locate the right and leftcoronary arteries. An over the wire introducer system, including aguidewire, is used to introduce the valve component 312 into the aorta18. After the guidewire has been placed into the left ventricle 204 viathe iliofemoral, subclavian, or carotid vessels, the valve component 312may be delivered through the common femoral artery and passed across thenative aortic valve 202. After performing an angiogram to delineate thelocation of the coronary arteries 182, the valve component 312 isreleased by unsheathing the delivery system, thereby permittingexpansion of the self-expanding frame 350, as shown in FIGS. 18-19 .

The balloon-expandable frame 34 may be now deployed by inflating theballoon within the delivery system. This deploys the frame 34 to thepredetermined expanded diameter 46 and advances the frame 34 intoengagement with the aortic annulus 210, thereby sealing the aorticannulus 210 such that fluid is permitted to pass from the left ventricle204 only through the valve 32 and the valve 32 is positioned in theaortic annulus 210 proximal to the coronary arteries 182, as shown inFIGS. 18-19 . The openings 318 of the uncovered section 360 of the valvecomponent 312 permit blood flow to the coronary arteries 182 for promotecirculation. It should be appreciated that the deployment of the valvecomponent 312 may be performed during rapid ventricular pacing (RVP).

Referring now to FIGS. 20-22 , another embodiment of a transcathetervalve component (hereinafter valve component 412) is shown. Somefeatures of the embodiment illustrated in FIGS. 20-22 are substantiallysimilar to those described above in reference to the proximal component212 of FIGS. 8-16 . Such features are designated in FIGS. 20-22 with thesame reference numbers as those used in FIGS. 8-16 . Similar to theproximal component 212 of FIGS. 8-16 , the valve component 412 includesa dual-frame 414 that extends from a proximal end 28 to a distal end 30.The frame 414 is attached to a valve 32 (shown in phantom), which ispositioned at the proximal end 28 of the component 412. In theillustrative embodiment, the valve 32 is configured as a bicuspid valve.When the valve component 412 is implanted into the patient's aorta 16,the valve 32 replaces the aortic valve and permits fluid (i.e., blood)to selectively pass from the heart and into a passageway 36 extendingthrough the valve component 412.

The dual-frame 414 includes a self-expanding outer frame 416 and aballoon-expandable inner frame 218 that is secured to the self-expandingouter frame 416 and houses the valve 32. Referring now to FIG. 9 , theself-expanding outer frame 416 has a generally hourglass shape and isformed from a metallic material, such as, nitinol, stainless steel, orother implant grade metallic material. It should be appreciated that inother embodiments the outer frame 416 may be formed from a polymericmaterial. The outer frame 416 includes an elongated proximal section220, an inwardly tapered section 422, an outwardly tapered middlesection 62, and an elongated distal section 64.

The elongated proximal section 220 of the outer frame 416 includes theproximal end 28 of the component 412 and has a distal end 224 connectedto a proximal end 226 of the inwardly tapered section 222. The proximalsection 220 is embodied as a tubular stent. It should be appreciatedthat in other embodiments the section 220 may be shaped as a prism,cone, or other geometric shape depending on the patient's anatomy.

In the illustrative embodiment, the proximal section 220 has a length228 that is equal to approximately 15 mm. The proximal section 220 alsohas a diameter 230 of approximately 32 mm. It should be appreciated thatin other embodiments the dimensions of the frame 416 may vary accordingto the anatomy of the patient. In the illustrative embodiment, thediameter 230 is oversized relative to the diameter of the aortic annulus210 such that an interference fit is created between the proximalsection 220 and the annulus 210 when the valve component 412 isimplanted, as described in greater detail below. As shown in FIG. 9 ,the proximal section 220 defines a passageway 232 in the outer frame416.

In the illustrative embodiment, collagen fibers 234 are attached to theproximal section 220 to aid in preventing paravalvular leaks andmigration of the valve component 412 within the aortic walls. The fibers234 extend outwardly from the proximal section 220 and inwardly into thepassageway 232. It should be appreciated that in other embodiments theouter frame 216 may be covered with hydrogel or other sealing materials.In other embodiments, a plurality of barbs or hooks may be attached tothe proximal section 220. The hooks may be configured to further engagethe tissue of the aorta and inhibit or prevent migration of the device10.

The inwardly tapered section 422 of the outer frame 416 includes theproximal end 226 and a distal end 236 connected to the proximal end 68of the outwardly tapered middle section 62. The section 422 tapersinwardly between the ends 226, 236 from approximately 32 mm at the end226 to approximately 22 mm at the end 236. In the illustrativeembodiment, the inwardly tapered section 422 has a length 238 ofapproximately 10 mm.

The outwardly tapered middle section 62 of the self-expanding frame 416has the proximal end 68 and a distal end 72 connected to the proximalend 74 of the elongated distal section 64. The section 62 tapersoutwardly from a diameter of approximately 22 mm at the end 68 to adiameter of approximately 28 mm at the end 72. In the illustrativeembodiment, the middle section 62 has a length 76 of approximately 10mm. In other embodiments, the dimensions of the section 62 may varydepending on, for example, the patient's anatomy.

The elongated distal section 64 of the self-expanding frame 416 extendsdistally from the proximal end 74 to the distal end 30 of the component412. In the illustrative embodiment, the section 64 has a length 78 thatis greater than the combined length of the tapered sections 60, 62. Inone particular non-limiting example, the length 78 of the elongateddistal section 64 is approximately 30 mm and has a diameter 80 ofapproximately 34 mm. In other embodiments, the dimensions of the section64 may vary depending on, for example, the patient's anatomy. In oneexemplary embodiment, the distal section 64 may taper between theproximal end 74 and the distal end 30.

As shown in FIG. 20 , each of the proximal section 220 and the inwardlytapered section 422 of the self-expanding frame 416 is formed in anopen-cell stent configuration, and each of the sections 62, 64 is formedin a Z-stent configuration. It should be appreciated that in otherembodiments the sections 62, 64, 220, 422 may be formed in a singleconfiguration, including the open-cell stent configuration, mesh-likestent configuration, or Z-stent configuration. The sections 62, 64, 220,422 may also be formed as a single monolithic component. The outersurfaces 440 of the sections 62, 64 are covered with low profilepolyester, ePTFE, or other nonporous covering material 442 such thatfluid is prevented from passing through the surface 440. The outersurface 444 of the section 422 is uncovered such that fluid is permittedto pass through openings 446 defined in the surface 444. The uncovered,open cell section 422 is configured to allow for coronary arteryperfusion. The covered sections 62, 64 serve to stabilize the valvecomponent 412 against the aorta 18 and provide a docking station toascending aortic extensions or fenestrated/branch arch grafts.

As described above, the outer frame 416 of the dual-frame 414 is securedto a balloon-expandable inner frame 218, which is positioned in thepassageway 232 and houses the valve 32. As described above, theballoon-expandable frame 218 is expandable during implantation from anunexpanded diameter 450 to the expanded diameter (not shown).

To deploy the valve component 412, a stiff wire is passed through theaortic valve 202 into the left ventricle 204. The delivery system forthe valve component 412 is then passed through the valve 202. When thedelivery system is in position, the valve component 412 is released byunsheathing the system, thereby permitting expansion of theself-expanding frame 416. The proximal section 220 of the frame 416expands into engagement with the aortic annulus 210, thereby creating aninterference fit between the frame 416 and the annulus 210 andstabilizing the valve component 412 in place. As shown in FIG. 21 , theinner frame 218 is initially unexpanded within the outer frame 416. Theinner frame 218 may be deployed by expanding the balloon assembly.Expansion of the balloon-expandable inner frame 218 engages the innerframe 218 with the outer frame 416 and compresses the collagenfiber/hydrogel coated proximal section 220 of the outer frame 416against the aortic annulus 210.

As shown in FIG. 22 , the combined engagement of the frames 218, 416seals the annulus 210 and the paravalvular areas, and thus, preventsparavalvular leakage. As such, fluid is permitted to pass from the leftventricle 204 only through the valve 32 of the component 412. Theopenings 446 of the uncovered section 422 of the valve component 412permit blood flow to the coronary arteries 182 for promote circulation.

It should be appreciated that the design of components 12, 14, 212 andthe transcatheter valves 312, 412 has intentionally taken into accountthe potential failure modes and allows for correction of any suchfailure modes. For example, with respect to components 12, 14, 212,paravalvular leaks may be corrected. More specifically, with respect toa paravalvular leak (type Ia endoleak), leakage around the valve 32would act as a type la endoleak. The trapdoors 86 in components 12, 312would allow for coil embolization of the area of the leak. Two trapdoorsat 180 degree location would allow access to the entire area above theaortic annulus. Since the coronary arteries 182 are protected by theconduits 22 in the distal component 14, coil embolization of this areawould not compromise the coronary blood flow. Coil embolization ofparavalvular leaks are already being performed clinically after heartvalve surgery if there are additional leaks around the valve.

Aortic insufficiency (Al) after implantation may also be corrected.Significant Al has been documented in up to 17% of patients aftertranscatheter valve implantation. Except heavy annular calcification,the tricuspid morphology of the current valves and the ovoid shape ofthe aortic annulus can cause malcoaptation of the valve leaflets causingAl. The bicuspid valve nature of the designs discussed hereinpotentially eliminates the problem with malcoaptation and AI secondaryto that.

Structural valve degeneration may also be corrected. More specifically,the bicuspid valve design allows for placement of another transcathetervalve across the first device without compromising valvular flow area.

Coronary insufficiency may also be corrected. The Cabrol endo-conduits22 in conjunction with the tapered section 128 of component 14 ensureuninterrupted coronary blood flow. By first deploying the component 14,the surgeon will be able to work through the Cabrol conduits 22 andusing standard catheters and guidewires to cannulate the right and leftcoronary arteries. Stents 24 are deployed from the coronary arteriesinto the Cabrol conduits 22. Deployment the component 12 or component212 may be delayed until coronary blood flow is secured. The tapereddesign will mitigate the risk of compression of the coronary stentsbetween the device 10 and the aortic wall.

For the transcatheter valves 312, 412, paravalvular leaks may also becorrected in that the open cell midsections 360, 422 of the valve allowthe cannulation and stenting of the coronary arteries with potentialcoil embolization of the leak after the protection of the coronaryartery if necessary.

Structural valve degeneration in the transcatheter valves 312, 412 maybe corrected in that the bicuspid valve design permit for placement ofanother transcatheter valve across the first device without compromisingvalvular flow area.

The dual frame component may also take the form of other transcathetervalvular replacement devices such as, for example, prosthetic mitral andtricuspid valves. The dual frame component may also be used to enhancesealing zones of endovascular devices to treat abdominal and thoracicaneurysms, and in applications to treat peripheral vascular disease.

It will be appreciated that the devices and methods described hereinhave broad applications. The foregoing embodiments were chosen anddescribed in order to illustrate principles of the methods andapparatuses as well as some practical applications. The precedingdescription enables others skilled in the art to utilize methods andapparatuses in various embodiments and with various modifications as aresuited to the particular use contemplated. In accordance with theprovisions of the patent statutes, the principles and modes of operationof this disclosure have been explained and illustrated in exemplaryembodiments.

It is intended that the scope of the present methods and apparatuses bedefined by the following claims. However, it must be understood thatthis disclosure may be practiced otherwise than is specificallyexplained and illustrated without departing from its spirit or scope. Itshould be understood by those skilled in the art that variousalternatives to the embodiments described herein may be employed inpracticing the claims without departing from the spirit and scope asdefined in the following claims.

The scope of the disclosure should be determined, not with reference tothe above description, but should instead be determined with referenceto the appended claims, along with the full scope of equivalents towhich such claims are entitled. It is anticipated and intended thatfuture developments will occur in the arts discussed herein, and thatthe disclosed systems and methods will be incorporated into such futureexamples. Furthermore, all terms used in the claims are intended to begiven their broadest reasonable constructions and their ordinarymeanings as understood by those skilled in the art unless an explicitindication to the contrary is made herein. In particular, use of thesingular articles such as “a,” “the,” “said,” etc. should be read torecite one or more of the indicated elements unless a claim recites anexplicit limitation to the contrary. It is intended that the followingclaims define the scope of the disclosure and that the method andapparatus within the scope of these claims and their equivalents becovered thereby. In sum, it should be understood that the disclosure iscapable of modification and variation and is limited only by thefollowing claims.

1. (canceled)
 2. A heart valve assembly comprising: a. an inner framecomprising a graft covering housing a prosthetic heart valve, whereinthe graft covering extends around the prosthetic heart valve forproviding sealing to the heart valve; b. an outer frame formed from ametallic material and defining a gridded configuration, and beingsecured to the graft covering by a plurality of stitches; and c. asealing material positioned externally to the outer frame for providingsealing between the outer frame and a patient's anatomical wall toprevent paravalvular leaks, wherein the sealing material includes aplurality of radially extending fibers that extend outwardly of theouter frame; wherein the graft covering is made of polyester,polytetrafluoroethylene, expanded polytetrafluoroethylene, or a polymer.